The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia

NCT ID: NCT06403982

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2025-12-31

Brief Summary

The aim of this study is to determine the influence of oxytocin on fetal well-being during labor in patients receiving epidural analgesia (ELA) with the use of cardiotocography (CTG) and doppler ultrasonography.

CTG is a commonly used technique to monitor the fetal heartbeat and contractions of uterus during pregnancy and labor. The maternal-fetal doppler ultrasonography is a non-invasive method used for the pregnancy surveillance.

Various psychological and psychosocial factors impact the perception of labor pain. Its intensity is described differently by each patient - some claim it to be the worst pain that they experienced during their lives. Usually, the labor pain is more severely experienced by the patients giving birth for the first time and those with induced labor.

Nowadays, there are many non-pharmacological (e.g. acupuncture, massage, TENS) and pharmacological (anesthetic gas, opioids, ELA) methods of labor pain management. ELA is a regional anesthesia, in which the anesthetic drug is injected into the epidural space with the aim to block the pain experienced by the patient without impacting patients ability to move or push during labor. The safety of the procedure is well-discussed and documented in Cochrane review from 2018, which shows no adverse impact on the proportions of Caesarean section, long-term backache, or neonatal outcomes. It is considered to be a golden standard for labor pain management.

Oxytocin is a well-known hormone used for the induction of labor and to stimulate the uterine contraction during labor. The impact of oxytocin alone on CTG pattern and maternal-fetal doppler ultrasonography is discussed in the literature. However, the cumulative effect of ELA and oxytocin remains unclear. Some researchers claim that ELA increases the frequency of uterine contractions and that the additional use of oxytocin leads to higher risk of uterine hyper-stimulation and unreassuring CTG patterns. Whereas the others state that ELA weakens the strength of uterine contractions leading to slow progression of labor and the need to use or increase the use of oxytocin.

There are no data on how the cumulative use of oxytocin and ELA impacts the maternal-fetal flows during labor.

Detailed Description

This is a randomized controlled trial performed at the Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration. The study will recruit 200 patients in either labor induced by oxytocin or stimulated with oxytocin at 37-42 weeks of gestation, requesting the epidural labor analgesia (ELA) and meeting the inclusion criteria. The patients will be individually randomized to either the study group (n=100), in which the use of oxytocin will be continued after the administration of ELA; or to the control group (n=100), in which the oxytocin will be changed to 0.9% sodium chloride solution after the ELA administration.

The vital signs (blood pressure, saturation, heart rate) and the Doppler velocities in the uterine arteries, umbilical artery and the fetal middle cerebral artery will be measured directly before the administration of ELA and then after 30, 60 and 120 minutes. After 2 hours the patients will be examined to assess the progress of labor. If no progress is detected due to the secondary weakening of uterus contractile function, the oxytocin will be reintroduced in the control group.

Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

The labor and neonatal outcomes (e.g mode of the delivery, duration of labor, Apgar score, umbilical artery blood gas analysis) will also be recorded.

Conditions

Uterine Contraction; Oxytocin; Labor Progress; Fetal Doppler; Labor Epidural Analgesia; Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Oxytocin Group

Oxytocin Group will comprise 100 women in labor either stimulated or induced by oxytocin requesting epidural analgesia (ELA). The use of oxytocin will be continued after the administration of ELA.

Group Type: EXPERIMENTAL

Continuation of oxytocin after ELA

Intervention Type: OTHER

The use of oxytocin will be continued after the administration of ELA. The vital signs (blood pressure, saturation, heart rate) and the Doppler velocities in the uterine arteries, umbilical artery and the fetal middle cerebral artery will be measured directly before the administration of ELA and then after 30, 60 and 120 minutes. After 2 hours the patients will be examined to assess the progress of labor.

Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

Control Group

Control Group will comprise 100 women in labor either stimulated or induced by oxytocin requesting epidural analgesia (ELA). The oxytocin pump will be changed to 0.9% sodium chloride solution pump after the administration of ELA.

Group Type: PLACEBO_COMPARATOR

Discontinuation of oxytocin after ELA

Intervention Type: OTHER

The oxytocin pump will be changed to 0.9% sodium chloride solution pump after the administration of ELA. The vital signs (blood pressure, saturation, heart rate) and the Doppler velocities in the uterine arteries, umbilical artery and the fetal middle cerebral artery will be measured directly before the administration of ELA and then after 30, 60 and 120 minutes. After 2 hours the patients will be examined to assess the progress of labor. If no progress is detected due to the secondary weakening of uterus contractile function, the oxytocin will be reintroduced. Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

Interventions

Continuation of oxytocin after ELA

The use of oxytocin will be continued after the administration of ELA. The vital signs (blood pressure, saturation, heart rate) and the Doppler velocities in the uterine arteries, umbilical artery and the fetal middle cerebral artery will be measured directly before the administration of ELA and then after 30, 60 and 120 minutes. After 2 hours the patients will be examined to assess the progress of labor.

Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

Intervention Type: OTHER

Discontinuation of oxytocin after ELA

The oxytocin pump will be changed to 0.9% sodium chloride solution pump after the administration of ELA. The vital signs (blood pressure, saturation, heart rate) and the Doppler velocities in the uterine arteries, umbilical artery and the fetal middle cerebral artery will be measured directly before the administration of ELA and then after 30, 60 and 120 minutes. After 2 hours the patients will be examined to assess the progress of labor. If no progress is detected due to the secondary weakening of uterus contractile function, the oxytocin will be reintroduced. Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years old
• singleton pregnancy
• labor induced by oxytocin or stimulated with oxytocin
• signed informed consent form
• cervical dilation ≥ 3cm
• patient requesting and eligible for epidural analgesia
• normal CTG trace for at least 30 minutes before epidural analgesia

Exclusion Criteria

• less than 18 years old
• preterm delivery
• multiple pregnancy
• fetal malformations
• less than 3cm cervical dilation
• lack of CTG trace for at least 30 minutes before epidural analgesia
• patient not requesting or not eligible for epidural analgesia
• informed consent form not signed
• spontaneous labor without the use of oxytocin

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: collaborator

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

OTHER

Sponsor Role: lead

Responsible Party

Król Joanna

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Department of Obstetrics and Perinatology, National Medical Institute of the Ministry of the Interior and Administration

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

References

Ye Y, Song X, Liu L, Shi SQ, Garfield RE, Zhang G, Liu H. Effects of Patient-Controlled Epidural Analgesia on Uterine Electromyography During Spontaneous Onset of Labor in Term Nulliparous Women. Reprod Sci. 2015 Nov;22(11):1350-7. doi: 10.1177/1933719115578926. Epub 2015 Mar 29.

Reference Type: BACKGROUND

PMID: 25824008 (View on PubMed)

Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.

Reference Type: BACKGROUND

PMID: 29781504 (View on PubMed)

Lurie S, Feinstein M, Heifetz C, Mamet Y. Epidural analgesia for labor pain is not associated with a decreased frequency of uterine activity. Int J Gynaecol Obstet. 1999 May;65(2):125-7. doi: 10.1016/s0020-7292(99)00005-3.

Reference Type: BACKGROUND

PMID: 10405055 (View on PubMed)

Abrao KC, Francisco RPV, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):41-47. doi: 10.1097/AOG.0b013e31818f5eb6.

Reference Type: BACKGROUND

PMID: 19104358 (View on PubMed)

Other Identifiers

KB 26/2024

Identifier Type: -

Identifier Source: org_study_id